EC grants approval for ranibizumab

Basel, Switzerland-The European Commission (EC) has approved a new indication for ranibizumab (Lucentis, marketed by Genentech in the United States and Novartis in the rest of the world): treating patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

The action makes ranibizumab the first anti-vascular endothelial growth factor (VEGF) therapy licensed for the treatment of both BRVO and CRVO in the European Union.

The approval was based on data from two pivotal phase III studies-BRAVO in BRVO patients and CRUISE in CRVO patients-that showed early and sustained improvement in vision in patients at 6 months with monthly ranibizumab treatment compared with the standard of care. Visual acuity gains were maintained from months 7 through 12 with as-needed dosing of ranibizumab, according to Novartis.

“[Ranibizumab] has proven to be an important therapy for people with difficult-to-treat eye conditions, including wet age-related macular degeneration (AMD) and patients with vision loss due to diabetic macular edema (DME),” said David Epstein, division head of Novartis Pharmaceuticals.

In BRAVO, about 60% of patients with BRVO treated with monthly ranibizumab gained at least 15 letters of visual acuity at 6 months, compared with 29% of those treated according to current standard practice. Mean gains from baseline in visual acuity at 6 months were 18.3 letters for patients with BRVO, compared with gains of 7.3 letters with current standard practice.

In CRUISE, about 48% of patients with CRVO treated with monthly ranibizumab gained at least 15 letters of visual acuity at 6 months, compared with 17% of those treated according to current standard practice. Mean gains from baseline in visual acuity at 6 months were 14.9 letters for patients with CRVO, compared with gains of 0.8 letters with current standard practice.

Safety data from the BRAVO and CRUISE trials were similar to those of previous studies with ranibizumab in patients with wet AMD and visual impairment due to DME, according to Novartis, and no new adverse events were reported. At 6 months, the most common ocular adverse events that occurred in the ranibizumab-treated patients included conjunctival hemorrhage (48%) and eye pain (17%).